Reliable profile [Study As­sess­ment]

posted by jag009  – NJ, 2013-04-25 22:19 (4811 d 02:17 ago) – Posting: # 10496
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Hi Helmut!

PPI? :-D


Nope.

Test or Reference?


Reference

Sample size?


40

2×2 or replicate?


Rep - of the 2 reference arm

His other reference and test arms have more concentration values but still many BLQs. His "meaningful" profiles are lower in magnitude than other subjects and yes there are subjects with comparable "small" values. The questionable part is the reference arm with only 2 datapoints. AUC is defintely smaller than other subject.

From what I understand and being taught (by old schoolers) is never drop a subject... But this one is strange because there are only two points and they are next to each other (I guess, Cmax and post Cmax)...

Thanks
John

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